ASPARTATE AMINO TRANSFERASE

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE SAMPLE CONTAINING A SUBSTANCE THAT STRONGLY ABSORBS AT 340 NM, THE MEASURING WAVELENGTH OF THE ASSAY. THE EVENT WAS A SAMPLE-SPECIFIC ISSUE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

Additional Manufacturer Narrative

MEDWATCH FIELDS D4 CATALOG NO AND PRIMARY UDI NUMBER, AND G4 PMA / 510K (PREMARKET NUMBERS) WERE UPDATED.

Additional Manufacturer Narrative

ON (B)(6) 2025, FURTHER TESTING OF THE SAMPLE GENERATED THE FOLLOWING RESULTS: ALT 6.8 U/L WITH A DATA FLAG AND 7.8 U/L WITH A DATA FLAG. AST 16.7 U/L WITH A DATA FLAG AND 12.9 U/L. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM THE COBAS 8000 C702 MODULE. THE CUSTOMER SUSPECTED INTERFERENCE, AS THE SAMPLE IN QUESTION WAS COLLECTED 17 HOURS AFTER THE PATIENT HAD RECEIVED RED BLOOD CELLS DUE TO BEING ANEMIC. THE INITIAL AST (ASPARTATE AMINOTRANSFERASE) RESULT WAS 17.6 U/L WITH AN ANALYZER ALARM. THE INITIAL ALT (ALANINE AMINOTRANSFERASE) RESULT WAS 11.3 U/L WITH AN ANALYZER ALARM. DUE TO THE ALARM, A 1:10 AUTO DILUTION WAS PERFORMED. THE RESULT FOR AST WAS 2.2 U/L, AND THE RESULT FOR ALT WAS 10.3 U/L. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025, AND THE AST AND ALT RESULTS HAD NO FLAGS. NO SPECIFIC DATA WAS PROVIDED. THIS MEDWATCH IS FOR AST (ASPARTATE AMINOTRANSFERASE). REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR THE ALT (ALANINE AMINOTRANSFERASE) ASSAY.

Additional Manufacturer Narrative

THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.